Clinical Research Associate

If you’re inspired by improving lives, driven by innovation, and motivated to solve meaningful challenges, there’s a place for you at Senseonics. Senseonics is a medical technology company dedicated to transforming diabetes management through long-term, implantable continuous glucose monitoring systems. Our team is united by a shared mission: to deliver life-changing technology that empowers people with diabetes and the healthcare professionals who care for them. At Senseonics, we put our customers first, challenge ourselves to innovate boldly, and embrace learning as we push the boundaries of what’s possible. We work with urgency, take ownership of our results, and collaborate as one team to deliver solutions that make a real difference. Working at Senseonics isn’t just a job—it’s an opportunity to help pioneer the future of diabetes care. Job Summary: The Clinical Research Associate will be responsible for the overall clinical study conduct of clinical trials to ensure compliance with protocol(s) and Federal regulations, ICH and GCPs, and local requirements. Responsibilities: Responsible for planning and implementing activities required to manage clinical trials and ensures adherence to Good Clinical Practices (GCP), ICH guidelines, FDA regulations, MDR requirements, SOPs, and protocols; take ownership for data completion and accuracy. Contribute to clinical site interactions, including assistance with IRB/EC applications, contract negotiations, enrollment tracking, clinical trial material and supply requests, issue resolution, etc. Conduct frequent site visits as required throughout the duration of the study, international and domestic. Train clinic sites on proper product use and operation, including hands on training on sensor insertion and removal. Perform and manage all on-site and remote monitoring visits as well as support subject study visits to ensure site protocol compliance Act as the primary liaison between the sponsor and investigators for multiple sites and studies Coach and mentor junior CRAs (CRA I/II) and Clinical Trial Assistants (CTAs), assisting in their training and development. Maintain Trial Master Files (TMF) and ensure audit readiness of assigned sites. Assist with study feasibility, site selection, and vendor management, including tracking enrollment rates and study budgets Effectively manage external team/vendors activities including CRO, central lab, IRB and other external contractors. Support commercialization efforts by assisting in the development of clinical training and education materials related to the use of the product. Requirements: Must have a minimum 4-year undergraduate degree in Natural Sciences or Engineering. Preferred is a graduate degree in same disciplines. Must have a minimum of 1-3 years of applied experience in Clinical Sciences. Preferred experience in implantable medical device industry Strong analytical, communication, and organizational skills, along with proficiency in Microsoft Office and CTMS/EDC systems. Strong writing skills, experience with clinical trial report writing Must be able to travel extensively, 50-60 % (domestic and international), many times on short notice Well-versed in clinical aspects of GCP, FDA, AIMDD, ISO 14155 and other relevant experiences